BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 13258526 · Received January 14, 2022

    Report

    Report Number
    3004209178-2022-00656
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Report Date
    January 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000384357
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE (REP) RECEIVED A QUESTION ABOUT IMPEDANCES FROM AN HEALTHCARE PROVIDER ABOUT A PATIENT. THE CALLER INDICATED THAT THE IMPEDANCE OVERVIEW SHOWED THE LEFT SUBTHALAMIC NUCLEUS ELECTRODES 0 AND 1 WITH THE RED INDICATOR. THE CALLER PROVIDED THE FOLLOWING OF IMPEDANCE VALUES: L MONOPOLAR 0 1 ELECTRODES HAVE GREEN INDICATORS WITH VALUES OF 1314OHMS FOR BOTH 03 2212 13 2212 23 2164 02 2067 12 2061 01 LOW. THE PATIENT IS NOT GETTING EFFECTIVE THERAPY WITH ELECTRODE 2 AND 3, THE NOTE FROM THE HCP SAID THAT THE PATIENT DOES NOT GET ADEQUATE SYMPTOM RELIEF. THE CALLER WAS NOT WITH THE PATIENT. TECHNICAL SERVICES REVIEWED INFORMATION ABOUT IMPEDANCES. THE CALLER WILL FOLLOW UP WITH THE HEALTHCARE PROVIDER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE LOW IMPEDANCE WASN'T DETERMINED AND NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730251 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00763000384357

    Patients

    Seq Age Sex Outcome Treatment
    1 Female